BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENX LASER SYSTEM

    MDR report key: 2478944 · Received March 2, 2012

    Report

    Report Number
    3008772169-2012-00007
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 4, 2012
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY ENGINEER WAS DISPATCHED TO INVESTIGATE ENERGY ERRORS THAT WERE OCCURRING ON THIS LASER SYS AS PART OF A SEPARATE COMPLAINT INVESTIGATION. THE INVESTIGATION REVEALED THE ENERGY OUTPUT WAS BELOW SPEC. THE SYS WAS THEN CALIBRATED AND CONFIRMED TO BE WITHIN SPECS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. IT SHOULD BE NOTED THAT ALTHOUGH THE LASER SYS ENERGY WAS LOW AROUND THE TIME OF THIS EVENT, THERE WAS NO REPORT OF AN INCOMPLETE CAPSULOTOMY AND THE TEAR OCCURRED DURING HYDRODISSECTION. ALTHOUGH THE DEVICE WAS OUT OF SPEC, IT CANNOT BE CONCLUDED THAT THE LOW ENERGY CAUSED OR CONTRIBUTED TO THE CAPSULAR TEAR. CAPSULAR TEARS ARE AN INHERENT RISK OF CATARACT SURGERY. ROOT CAUSE LIKELY ASSOCIATED WITH PRESSURE DURING HYDRODISSECTION AND INTRACAPSULAR GAS FROM THE LENS FRAGMENTATION MAY HAVE BEEN A CONTRIBUTING FACTOR. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT HE EXPERIENCED AN ANTERIOR RADIAL CAPSULAR TEAR THAT OCCURRED DURING HYDRODISSECTION. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A SULCUS IOL WAS IMPLANTED AND THE PT DID WELL. ONE DAY POSTOPERATIVELY, THE PT'S UNCORRECTED DISTANCE VISUAL ACUITY WAS 20/20 WITH NO CELLS IN THE ANTERIOR CHAMBER OR VITREOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention